search
Back to results

Pain Relief Investigation of NeuroModulation Therapy in Adult Humans

Primary Purpose

Chronic Musculoskeletal Pain

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PRIMA
Sponsored by
Fralex Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Chronic Musculoskeletal Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 11, 2005
    Last Updated
    March 2, 2006
    Sponsor
    Fralex Therapeutics
    Collaborators
    PharmaNet
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00253032
    Brief Title
    Pain Relief Investigation of NeuroModulation Therapy in Adult Humans
    Official Title
    PRIMA Study: Pain Relief Investigation of NeuroModulation Therapy in an Adult Population: A Double Blind, Randomized, Multicenter, Placebo Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2006
    Overall Recruitment Status
    Terminated
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Fralex Therapeutics
    Collaborators
    PharmaNet

    4. Oversight

    5. Study Description

    Brief Summary
    The study is being performed to determine the efficacy and safety of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Musculoskeletal Pain

    7. Study Design

    Study Phase
    Phase 3

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    PRIMA

    10. Eligibility

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33025213
    Citation
    Sepulveda-Sanchez JM, Gil-Gil M, Alonso-Garcia M, Vaz Salgado MA, Vicente E, Mesia Barroso C, Rodriguez Sanchez A, Duran G, De Las Penas R, Munoz-Langa J, Velasco G, Hernandez-Lain A, Hilario A, Navarro Martin M, Benavides M, Oleaga L, Cantero Montenegro D, Ruano Y, Sanchez-Gomez P, Martin-Soberon MC, Morales-Llombart R, Pachon V, Pineda E. Phase II Trial of Palbociclib in Recurrent Retinoblastoma-Positive Anaplastic Oligodendroglioma: A Study from the Spanish Group for Research in Neuro-Oncology (GEINO). Target Oncol. 2020 Oct;15(5):613-622. doi: 10.1007/s11523-020-00754-6.
    Results Reference
    derived

    Learn more about this trial

    Pain Relief Investigation of NeuroModulation Therapy in Adult Humans

    We'll reach out to this number within 24 hrs